NA 96-1683Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295239819), received between Sep 1, 2017 and May 16, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THE RUBBER SEALS ON SEVERAL TRIALS WERE TORN. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036544 ↗
• MalfunctionAug 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM TRIAL WILL NOT FIT PROPERLY ON THE 45 MM TIBIA BROACH. STEM TRIAL WILL ALSO NOT FIT PROPERLY ON THE 34 MM AND THE 31 MM FEMORAL BROACH. 16 MM REAMER COMES LOOSE FROM THE HUDSON ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 12273575 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR CRACKED WHILE BROACHING WITH 31 BROACH, PREPPING THE FEMUR FOR A TC3/31 SLEEVE/ 14 MM STEM. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10252268 ↗
• MalfunctionNov 25, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  PROBLEM: IT IS VERY DIFFICULT TO CLEAN THE BROACH SLEEVE AND THE GASKETS. ACCORDING TO ATTACHED PICTURES THE BROACH SLEEVE IS STILL DIRTY AFTER CLEANING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369516 ↗
• MalfunctionMar 6, 2019Component Missing; Scratched Material; Component Missing; Scratched Material

  IT WAS REPORTED THAT THE RUBBER RING WAS MISSING NOT ALLOWING THE STEM TRIALS TO STAY IN GAUGED. ALL 2 PIECES WERE LOCATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8395146 ↗
• MalfunctionApr 25, 2018Component Missing; Component Missing

  ROUTINE INSPECTION OF INSTRUMENTS INDICATED FRAYED METAL ON ONE INSTRUMENT, AND A MISSING ORANGE INSERT ON A SECOND INSTRUMENT. PATIENT CONSEQUENCE? :NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457734 ↗
• MalfunctionApr 18, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE MBT STEM TRIALS ONLY LOOSELY ATTACHED TO BOTTOM OF TC3 BROACH TAKING OUT OF ROTATION OUT OF CAUTION. NO IMPACT ON CASE. NO DELAY, FOUND ON CLEAN UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439627 ↗
• MalfunctionSep 1, 2017Break; Material Disintegration; Break; Material Disintegration

  IT WAS REPORTED THAT THE O-RING HAS STARTED TO DISINTEGRATE.

  Patient problems: No Information

  MAUDE report 6838050 ↗